A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly
This study is designed to be a prospective cohort study conducted at the First Hospital of Jilin University. The target populations of this study are patients with Middle- and High-risk Acute Myeloid Leukemia in the elderly who received intermediate-dose cytarabine in combination with venetoclax for consolidation therapy from June 1, 2025to December 31, 2026. It is expected to enroll 68 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Elderly patients with Middle- and High-risk Acute Myeloid Leukemia who received the Intermediate-dose Cytarabine in Combination with Venetoclax at the First Hospital of Jilin University from March 1, 2024 to December 31, 2026.
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGRelapse-Free Survival(RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
MRD Negative Conversion Rate
Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
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